Fezolinetant Medicine 07 June 2022 Extended indication Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Fezolinetant Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Current proprietary name Already available biosimilars / generics Proprietary name VEOZA Manufacturer Astellas Portfolio holder Astellas Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Neurokinine-3-receptor antagonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2022 Expected Registration December 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Geregistreerd in december 2023 Therapeutic value Current treatment options De standaard geneesmiddelbehandeling voor vasomotorische symptomen in de menopauze is hormoontherapie met een combinatie van oestrogeen en progesteron, of oestrogeen alleen. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT04003155; NCT04003142; NCT05033886 Additional remarks Expected patient volume per year Patient volume < 10,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NHG-standaard, juni 2022; CBS, 2023; Marktinformatie; Depypere, J Clin Endocrinol Metab, December 2019, 104(12):5893–5905 Additional remarks De incidentie van overgangsklachten van menopauzale vrouwen tussen 45 en 64 jaar is 26 per 1.000 vrouwen per jaar. In Nederland betreft dit 62.644 vrouwen. 80% van deze vrouwen heeft vasomotorische symptomen (VMS) waarvan 40% matig tot ernstige VMS. Het percentage vrouwen waarvoor de behandeling met fezolinetant mogelijk meerwaarde heeft is de groep vrouwen die gecontra-indiceerd is voor hormoonbehandeling (25%) dan wel waarvoor waarschuwingen gelden voor het gebruik van hormoontherapie (25%). Hiermee komt het potentieel te behandelen aantal patiënten maximaal op 10.000. Expected cost per patient per year Cost References FK Additional remarks De apotheekinkoopprijs van een 28-daags verpakking (45mg) is €49,58. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References adisinsght Additional remarks Other information Additional remarks